510(k) · Cleared
ClearedGE Delta Software Option for Mri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 2, 2003 as substantially equivalent to K994282 (Medis Medical Imaging Systems BV, 2000) and 1 other predicate after a 9-day review. Its family tree reaches back 3 generations to 1994. 22 later devices descend from it.
- Decided
- Jul 2, 2003
- Review
- 9 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940172 (1994). 5 ancestors in all, the oldest K924605 (1993). 22 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 2 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 1 generation backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- This deviceK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- Descendant · cites it directly · 21 of its ownK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- Descendant · 3 generations on · 5 of its ownK191125 ADAS 3DGalgo Medical S.L · 2020
- Descendant · 3 generations on · 5 of its ownK162513 Arterys Software v2.0Arterys, Inc. · 2016
- Descendant · 4 generations on · 4 of its ownK210850 ADAS 3DAdas3D Medical S.L. · 2021
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K121762Cardiac VXGe Medical Systems, LLC · 2013 · cites it directly21descendants
- K140587MR-CT VvaMedis Medical Imaging Systems BV · 2015 · 2 generations on19descendants
- K191125ADAS 3DGalgo Medical S.L · 2020 · 3 generations on5descendants
- K162513Arterys Software v2.0Arterys, Inc. · 2016 · 3 generations on5descendants
- K210850ADAS 3DAdas3D Medical S.L. · 2021 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −2 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −1 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| 0 (this device) | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| +1 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| +2 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| +3 | K191125 | ADAS 3D | Galgo Medical S.L | 2020 | — |
| +3 | K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016 | — |
| +4 | K210850 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994282 | Mri- Flow Analytical Software PackageSummary page 2…diagnosis. 0 Comparison with Predicate The Delta Option is substantially equivalent to the features in currently marketed MEDIS Medical Imaging Systems FLOW (K994282) and MEDIS Medical Imaging Systems MASS (K994283). Both predicate devices are currently distributed by GEE Medical System… | 2000 |
| * | K994283 | Mri- Magnetic Resonance Analytical Software SystemSummary page 2…lta Option is substantially equivalent to the features in currently marketed MEDIS Medical Imaging Systems FLOW (K994282) and MEDIS Medical Imaging Systems MASS (K994283). Both predicate devices are currently distributed by GEE Medical Systems and manufactured by MEDIS. Summaty of Studies… | 2000 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121762 | Cardiac VX | 2013 | 21 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K121762 (Ge Medical Systems, LLC, 2013) has gone furthest, with 21 descendants of its own.
- 6 other devices also cite its predicate K994282.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization. A…
Read the full statement (163 words)
The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.
A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.
The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.
When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031927: GE Delta Software Option for Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031927
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026